FDA Orange Book · active-ingredient family
Hydrochlorothiazide; metoprolol tartrate
Hydrochlorothiazide; metoprolol tartrate is approved as 1 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:LOPRESSOR HCT · NDA 018303
1
Brand (NDA)
4
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LOPRESSOR HCTRLD×3 | VALIDUS PHARMS | NDA 018303 | AB | Dec 31, 1984 |
Generic (ANDA) products (4)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE×2 | SENORES PHARMS | ANDA 215789 | AB | Jan 08, 2025 | |
| METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE×3 | ALEMBIC | ANDA 202870 | AB | Nov 06, 2013 | |
| METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE×3 | SUN PHARM INDS | ANDA 090654 | — | Jan 19, 2012 | |
| METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE×3 | MYLAN | ANDA 076792 | AB | Aug 20, 2004 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Hydrochlorothiazide; metoprolol tartrate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
